Product Wiki · Recalls · Health Canada — Medical Devices

Optiflux Hemodialyzers (F250NRe)(2011-01-05) — recall 50549

Health Canada — Medical Devices · Canada · 2013-10-28 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
50549
Date of alert
2013-10-28
Country / jurisdiction
Canada
Authority classification
Type II
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Two lots of F25ONRe Dialyzer were recalled in February, 2011 (Incident ID 61779) due to increased complaints associated with internal blood leaks. Quality trending revealed that lot 10HU02012 and 10LU02016 demonstrated a higher blood leak rate than for other lots. Following a FDA inspection, a decision was made by the legal manufacturer to place additional 20 lots as they were manufactured under the same production process and could not be definitively segregated from the recalled lots.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/optiflux-hemodialyzers-f250nre

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